Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

Tracking Information
First Submitted Date ICMJE	March 22, 2013
First Posted Date ICMJE	March 26, 2013
Last Update Posted Date	December 28, 2016
Study Start Date ICMJE	March 2013
Estimated Primary Completion Date	December 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 22, 2013)	Cardioversion (time and percentage) [ Time Frame: 24 hours ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01818583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 10, 2015)	Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At about 3 months follow up, plus additional 3 days ECG-monitoring ]; The patients will be followed up with a resting ECG about three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.
Original Secondary Outcome Measures ICMJE; (submitted: March 22, 2013)	Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At 3 months follow up, plus additional 3 days ECG-monitoring ]; The patients will be followed up with a resting ECG three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.
Current Other Outcome Measures ICMJE; (submitted: March 22, 2013)	Adverse events [ Time Frame: During time of infusion ]
Original Other Outcome Measures ICMJE	Same as current
Descriptive Information
Brief Title ICMJE	Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
Official Title ICMJE	Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
Brief Summary	Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the general population. The prevalence of atrial fibrillation increases with age. Between 50 and 70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm. Another treatment option for conversion of atrial fibrillation and atrial flutter is electrical conversion. This is an effective treatment but requires anesthesia. Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such converting drugs all have potentially serious side effects and are expensive. Potassium, sodium, calcium, and magnesium molecules are the most important ions causing electric current in the heart tissue. Our hypothesis is that hypokalemia promotes atrial fibrillation/atrial flutter by a direct effect on cardiomyocytes. Accordingly, we also hypothesize that potassium infusion may convert atrial fibrillation/atrial flutter to normal sinus rhythm. If so, this would be an inexpensive treatment with potentially very few side effects.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Atrial Fibrillation; Atrial Flutter
Intervention ICMJE	Drug: Potassium chloride; Drug: Glucose 50 MG/ML
Study Arms	Experimental: Potassium Potassium chloride infusion at a rate of 15 mmol/h (60 mmol KCl in 1000 ml of 5% glucose with a concentration of 0.05 mmol/mL, flow rate 265 mL/h). If the serum Mg ≤0.8 mmol/L, MgSO4 infusion (0.5 mmol/kg/24 hours in 1000 mL NaCl 0.9% corresponding to an infusion rate of approximately 42 mL/hour) will also be administered. Intervention: Drug: Potassium chloride; Placebo Comparator: Placebo 5% glucose (flow rate 265 ml/h) as placebo infusion. Intervention: Drug: Glucose 50 MG/ML
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: December 24, 2016)	150
Original Estimated Enrollment ICMJE; (submitted: March 22, 2013)	218
Estimated Study Completion Date	March 2018
Estimated Primary Completion Date	December 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients with paroxysmal atrial fibrillation/atrial flutter with duration <48 hours; Plasma potassium ≤4,0 mmol/L.; Age ≥ 18 år Exclusion Criteria: Plasma potassium > 4,0 mmol/L; eGFR <30 mL/min; Patients on antiarrhythmic therapy (flecainid, amiodarone, dronedarone or sotalol); Pregnancy; Breast feeding; Patients participating in a clinical trial during the last six months; Addison disease, adynamia episodic hereditary, or Sickle cell anemia; Metabolic acidosis, pH < 7,2
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Erik Øie, MD, PhD +47-22454055 erik.oie@diakonsyk.no Contact: Kiarash Tazmini, MD +47-22451500 kiarash.tazmini@diakonsyk.no
Listed Location Countries ICMJE	Norway
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01818583
Other Study ID Numbers ICMJE	AK-01
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Kiarash Tazmini, Diakonhjemmet Hospital
Study Sponsor ICMJE	Diakonhjemmet Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Erik Øie, MD, PhD Diakonhjemmet Hospital
PRS Account	Diakonhjemmet Hospital
Verification Date	December 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP